Impact of One Versus Two Amino Acid Chelated Iron Capsules on Prevention of Iron Deficiency Anemia in Non-anemic Women With Twin Gestations

NCT02858505 | Completed Phase 2

• 1 other identifier: IDAT
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Anaemia is the most worldwide health problem affecting pregnant women in both developed and developing countries. During pregnancy there is an inconsistent increase in plasma volume and haemoglobin mass. Iron deficiency anemia is the commonest type of anemia during pregnancy. The pregnant woman needs about 1000 mg of iron during pregnancy. Diet alone cannot give pregnant woman the daily required amount of the iron (about 27 mg/day) so the Centers for Disease Control and Prevention recommend that pregnant women take a daily supplement of 30 mg of elemental iron as a preventive dose. As most women begin their pregnancy with low iron stores, particularly in the second and third trimesters, so prevention should start as soon as possible even before pregnancy to prevent depletion of iron store and further Iron deficiency anemia. Oral iron is a cheap, effective and relatively safe line to prevent Iron deficiency anemia during pregnancy. The common available ferrous salts include ferrous fumarate, ferrous sulphate and ferrous gluconate. Unfortunately; these iron forms are associated usually with constipation, darkened stools, diarrhea, loss of appetite, nausea, stomach cramps, and vomiting. Iron amino acid chelates have been emerged to be used as agents for prevention and treatment of Iron deficiency anemia. These agents provide maximum bioavailability and maximum efficacy with minimal unpleasant side effects. Twin pregnancies have a significant role in perinatal morbidity due to increased risks of low birth weight and preterm birth. The iron requirement for twin pregnancy is probable double fold that of a singleton pregnancy and maternal hemoglobin in twin gestations is usually lower than in singleton pregnancy resulting in higher rate of Iron deficiency anemia.

Conditions

Anemia

Outcome Measures

Primary Outcomes (1)

• Hemoglobin level

  24 weeks

Study Arms (2)

27 mg elemental iron group

ACTIVE COMPARATOR

received 27 mg elemental iron once daily starting at 12 weeks until 36 weeks

Drug: 27 mg elemental iron

54 mg elemental iron group

ACTIVE COMPARATOR

received 54 mg elemental iron once daily starting at 12 weeks until 36 weeks

Drug: 54 mg elemental iron

Interventions

27 mg elemental iron DRUG

27 mg elemental iron group

54 mg elemental iron DRUG

54 mg elemental iron group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• twin gestations
• ±12 weeks)
• normal hemoglobin level (Hb ≥ 120 g/L).
• women were living in nearby area to make up follow up quit possible
• willing to participate in our study

You may not qualify if:

• a recent blood transfusion
• threatened miscarriage
• pathological blood loss
• vegetarian diet
• intolerant to oral iron form
• history of haematologic disorder
• chronic diseases
• unwillingness to co-operate.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Women Health Hospital - Assiut university

Asyut, 71111, Egypt

Location

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: August 2, 2016
• First Posted: August 8, 2016
• Study Start: August 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: August 8, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)